Pioglitazone Add-on for Type 2 Diabetes Mellitus Control
This study aims to evaluate the effectiveness of Pioglitazone as an add-on treatment for Type 2 Diabetes Mellitus control, specifically observing changes in your HbA1c levels after 24 weeks of use.
Pioglitazone 15mg
+ Pioglitazone 30mg Placebo
+ Metformin≥1000mg
Treatment Study
Summary
Study start date: May 28, 2021
Actual date on which the first participant was enrolled.This study focuses on individuals who have Type 2 Diabetes and are not adequately managing their condition with Metformin and Dapagliflozin. The research aims to evaluate the effectiveness and safety of adding either Pioglitazone 15mg or Pioglitazone 30mg to their current treatment. The potential outcomes of this study could lead to improved care for those struggling to control their Type 2 Diabetes with current medications. During this study, participants will receive either Pioglitazone 15mg, Pioglitazone 30mg, or a placebo, in addition to their ongoing Metformin and Dapagliflozin treatment. The study will measure changes in HbA1c levels, a common indicator of blood sugar control, after 24 weeks of treatment. This will help determine if adding Pioglitazone to the current treatment plan results in improved blood sugar control.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.378 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 19 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: 1. Those who voluntarily signed the informed consent to participate in this study. 2. Adults aged 19 years or older. 3. Those diagnosed with type 2 diabetes mellitus. 4. Subjects taking constant doses of ≥1000mg of Metformin and 10 mg of Dapagliflozin for more than 8 weeks at Visit 1 (regardless of dosage forms (immediate-release and sustained-release) and single agent or combination drug.) 5. Subjects with 7% ≤ HbA1c ≤ 10.5% at Visit 1 and Visit 2 6. Subjects able to understand the study, comply with study procedures, and attend all scheduled visits. Exclusion Criteria: 1. Uncontrolled hyperglycemia at Visit 1 or Visit 2 (subjects with FPG \> 270 mg/dL as a result of the test conducted by the study institution.) 2. Medication compliance is \<70% or \>120% for each BR3003D, BR3003C, BR3003A-2, and BR3003B-2 during the Run-in period at Visit 2. 3. Patients with other types of diabetes instead of type 2 diabetes (e.g., type 1 diabetes, secondary diabetes, or congenital renal glycosuria). 4. Patients with uncontrolled, severe diabetic complications (e.g., proliferative diabetic retinopathy uncontrolled despite medication and severe diabetic neuropathy) 5. Those who suffered from acute or chronic metabolic acidosis within 3 months as of Visit 1, including lactic acidosis and diabetic ketoacidosis. 6. Those with \> 40 kg/m2 of BMI measured at Visit 1. 7. Those with uncontrolled hypertension at Visit 1 or Visit 2 (SBP \> 180 mmHg or DBP \> 110 mmHg). 8. Those diagnosed with cardiovascular diseases (myocardial infarction, stroke, unstable angina, and transient ischemic attack (TIA)) or undergo revascularization within 3 months as of Visit 1 9. Those with heart failure (NYHA class II\~IV) or who had suffered from heart failure. 10. Those who suffered from gastrointestinal diseases that may affect the absorption, distribution, metabolism, and excretion of investigational products or had underwent surgery; 11. Those who underwent surgery requiring general anesthesia within 4 weeks as of Visit 1 or who are scheduled to receive such surgery within 4 weeks after the study ends 12. Those with a history of malignant tumor within 5 years as of Visit 1 13. Those who have a clinically significant liver disease 14. Those who have a clinically significant renal disease 15. Those with clinically significant hematuria detected at Visit 1 or Visit 2 16. Those with chronic diseases requiring the continued use of systemic steroid or immunosuppressants (oral administration, injection, or inhalation). 17. Patients with pituitary insufficiency or adrenal insufficiency. 18. Those with clinically significant severe infection or trauma based on an investigator's judgement. 19. Patients with AIDS. 20. Patients with acute or chronic diseases that may cause histotoxic hypoxia such as respiratory failure and shock. 21. Those who need treatment due to dehydration caused by persistent diarrhea and vomiting or at a risk of fluid volume depletion. 22. Those who have been administered with the following drugs or expected to require the continued administration during the study period: * Those administered with systemic steroid agents (Prednisolone, \>30 mg/day) within 2 weeks as of Visit 1. * Those being administered with thyroid medications and whose dose has been modified within 6 weeks as of Visit 1 (however, dose reduction is accepted.) * Those being administered with diuretics and whose dose has been modified within 8 weeks as of Visit 1 however, dose reduction is accepted.) * Those who have been administered with antidiabetics other than Metformin and Dapagliflozin within 8 weeks as of Visit 1. * Those who have been administered with obesity drugs (e.g., phentermine, phendimetrazine, diethylpropion, and mazindol) within 12 weeks as of Visit 1. * Those who need to take prohibited concomitant medications stated here during the study period. 23. Those with history of alcohol or drug abuse within 1 year as of Visit 1. 24. Those who had allergic reaction to main ingredients or components of the investigational products. 25. Those who had genetic disorders such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption. 26. Females who are pregnant or breastfeeding. 27. Patients planning to become pregnant or of childbearing potential, but not using any recognized contraceptive method 28. Those who are currently participating in other ongoing clinical studies or those who have taken the investigational products from other clinical studies within 12 weeks as of Visit 1 29. Those who are judged unsuitable for the study by a principal investigator or investigators.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
Active ComparatorStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location